FdaApplication
NDA 019537
Identifiers
- fda_app_no: NDA019537
Properties
| Property | Value |
|---|---|
| applicant_name | BAYER HEALTHCARE PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1987-10-22 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL |
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL |
3 products